Vascular device for treating venous valve insufficiency

ABSTRACT

A vascular device for treating vein valve insufficiency including an elongated member, a first retention portion movable from a first elongated insertion position to an expanded position and a second retention portion movable from a first elongated insertion position to an expanded position. An intermediate looped portion is positioned between the first portion and the second portion. The valve is supported by the intermediate looped portion and is movable between an open position to allow blood flow therethrough and a closed position to inhibit blood flow therethrough. The intermediate looped portion is adjustable to loops of different diameters dependent on an inner diameter of the vessel wall.

This application claims priority from provisional application Ser. No.61/953,828, filed Mar. 15, 2014, the entire contents of which areincorporated herein by reference.

BACKGROUND

1. Technical Field

This application relates to a vascular device and more particularly to avascular device with a valve for treating venous valve insufficiency.

2. Background of Related Art

Veins in the body transport blood to the heart and arteries carry bloodaway from the heart. The veins have one-way valve structures in the formof leaflets disposed annularly along the inside wall of the vein whichopen to permit blood flow toward the heart and close to prevent backflow. That is, when blood flows through the vein, the pressure forcesthe valve leaflets apart as they flex in the direction of blood flow andmove towards the inside wall of the vessel, creating an openingtherebetween for blood flow. The leaflets, however, do not normally bendin the opposite direction and therefore return to a closed position toprevent blood flow in the opposite, i.e. retrograde, direction after thepressure is relieved. The leaflet structures, when functioning properly,extend radially inwardly toward one another such that the tips contacteach other to block backflow of blood.

In the condition of venous valve insufficiency, the valve leaflets donot function properly as they thicken and lose flexibility, resulting intheir inability to extend sufficiently radially inwardly to enable theirtips to come into sufficient contact with each other to preventretrograde blood flow. The retrograde blood flow causes the buildup ofhydrostatic pressure on the residual valves and the weight of the blooddilates the wall of the vessel. Such retrograde blood flow, commonlyreferred to as reflux, leads to swelling and varicose veins, causinggreat discomfort and pain to the patient. Such retrograde blood flow, ifleft untreated can also cause venous stasis ulcers of the skin andsubcutaneous tissue. There are generally two types of venous valveinsufficiency: primary and secondary. Primary venous valve insufficiencyis typically a condition from birth, where the vein is simply too largein relation to the leaflets so that the leaflets cannot come intoadequate contact to prevent backflow. More common is secondary venousvalve insufficiency which is caused by clots which gel and scar, therebychanging the configuration of the leaflets, i.e., thickening theleaflets creating a “stub-like” configuration. Venous valveinsufficiency can occur in the superficial venous system, such as thesaphenous veins in the leg, or in the deep venous system, such as thefemoral and popliteal veins extending along the back of the knee to thegroin.

A common method of treatment of venous valve insufficiency is placementof an elastic stocking around the patient's leg to apply externalpressure to the vein, forcing the walls radially inwardly to force theleaflets into apposition. Although sometimes successful, the tightstocking is quite uncomfortable, especially in warm weather, as thestocking must be constantly worn to keep the leaflets in apposition. Theelastic stocking also affects the patient's physical appearance, therebypotentially having an adverse psychological affect. This physical and/orpsychological discomfort sometimes results in the patient remove thestocking, thereby preventing adequate treatment.

Another method of treatment has been developed to avoid the discomfortof the stocking. This method involves major surgery requiring theimplantation of a cuff internally of the body, directly around the vein.This surgery requires a large incision, resulting in a long patientrecovery time, scarring and carries the risks, e.g., anesthesia,inherent with surgery.

Another invasive method of surgery involves selective repairing of thevalve leaflets, referred to as valvuloplasty. In one method, sutures areutilized to bring the free edges of the valve cusp into contact. Thisprocedure is complicated and has the same disadvantages of the majorsurgery described above.

Commonly assigned U.S. Pat. Nos. 6,695,878 and 6,527,800, the entirecontents of which are incorporated herein by reference, disclose amethod and device to minimally invasively treat venous valveinsufficiency without requiring an outer stocking or internal cuff. Suchdevice avoids the physical and psychological discomfort of an externalstocking as well as avoids the risk, complexity and expense ofsurgically implanted cuffs.

The device is advantageously inserted minimally invasively, i.e.,intravascularly, and functions to effectively bring the valve leafletsinto apposition. This device first expands against the vessel wall tograsp the wall, and then contracts to bring the vessel wall radiallyinwardly so the leaflets can be pulled closer together to a functionalposition.

The vascular device of commonly assigned U.S. Pat. No. 6,676,698, theentire contents of which are incorporated herein by reference, utilizesthe device of these foregoing U.S. Pat. Nos. 6,695,878 and 6,527,800 forbringing the vessel wall radially inwardly to correct the dilation ofthe wall, but rather than rely on the patient's existing valve leafletswhich may be scarred or non-functional, contains a replacement valve asa substitute for the patient's leaflets. Thus, advantageously, venousvalve insufficiency can be treated minimally invasively by bringing thevessel wall inwardly and replacing the patient's valve.

Commonly assigned U.S. Pat. No. 8,834,551 discloses another device forbringing the vessel wall radially inwardly for treating venous valveinsufficiency having retention arms extending to a distal end of thevalve. Commonly assigned U.S. Publication No. 2013-0289710 disclosesanother vascular device wherein release of the retention members causesthe struts to pull the vessel wall inwardly.

Although the foregoing devices have certain advantages in approximatingthe vessel wall, in certain applications such approximation might bedifficult or not achieve sufficient approximation as vessel walldiameters vary. There exists a need for a device for treating venousvalve insufficiency which relies on the existing vessel wall spacing butis adjustable to different size vessels and provides a replacementvalve. Such adjustability would advantageously enable the use of asingle device for different size vessels for implantation of a valve toreplace and simulate the patient's valve.

SUMMARY OF THE INVENTION

The present application provides in one aspect a vascular devicecomprising a body having a proximal portion and a distal portion andmovable from a collapsed elongated insertion position to an expandedposition having a larger cross-sectional dimension. The body includes aproximal looped portion, a distal looped portion and an intermediatevalve-supporting looped portion. The intermediate looped portionsupports a valve, wherein the valve is movable between an open positionto allow blood flow and a closed position to inhibit blood flow. Theintermediate looped portion is adjustable to different loop diametersdepending on a size of the vessel in which it is inserted.

In accordance with another aspect, the present invention provides avascular device for treating vein valve insufficiency comprising anelongated member having a first upstream portion and a second downstreamportion. A first retention portion at the upstream portion is movablefrom a first elongated insertion position to an expanded position, and asecond retention portion at the downstream portion is movable from afirst elongated insertion position to an expanded position. Anintermediate looped portion is positioned between the first portion andthe second portion. A valve is supported by the intermediate loopedportion and is movable between an open position to allow blood flowtherethrough and a closed position to inhibit blood flow therethrough.The intermediate looped portion is adjustable to loops of differentdiameters dependent on an inner diameter of the vessel wall.

In some embodiments, the first retention portion is a looped portionand/or the second retention portion is a looped portion. In someembodiments, the first retention portion includes first and secondlooped portions and/or the second retention portion includes first andsecond looped portions. In some embodiments, the first and secondretention portions are substantially perpendicular to a longitudinalaxis of the elongated member. In some embodiments, the first and secondretention portions extend on only one side of the elongated member.

In some embodiments, a collar is mounted on the intermediate loopedportion. In some embodiments, first and second members extend from theintermediate looped portion to retain the valve. In some embodiments,the second member is slidable with respect to the intermediate loopedportion and in some embodiments is attached to a first collar mounted onthe intermediate looped portion and slidable within a second collar. Insome embodiments, the first member is fixedly attached to theintermediate looped portion.

In some embodiments, the elongated member, the intermediate loopedportion, the first retention portion and the second retention portionare formed from a single wire. The valve can in some embodiments have asubstantially conical configuration.

The device can include a retrieval structure at the upstream and/ordownstream portions of the elongated member for retrieval of the device.

In accordance with another aspect, the present invention provides amethod for treating venous valve insufficiency comprising:

providing a vascular device including an elongated portion, downstream,upstream and intermediate looped portions extending radially from theelongated portion, and a valve attached to the intermediate loopedportion;

inserting into a target vessel a delivery device and the vascular devicein an insertion position within the delivery device, wherein in theinsertion position the downstream, upstream and intermediate loopedportions have a reduced transverse dimension; and

exposing the vascular device from the delivery device, wherein exposingthe vascular device enables the downstream, upstream and intermediatelooped portions to move to expanded positions, the intermediate loopedportion engaging an internal wall of the vessel and automaticallyadjusting to a diameter of the vessel.

In some embodiments, the diameter of the valve is adjusted by a radialsupport attached to the valve and slidably connected to the intermediatelooped portion. In some embodiments, a collar is mounted to theintermediate looped portion, and the radial support is slidable withinthe collar.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiment(s) of the present disclosure are described hereinwith reference to the drawings wherein:

FIG. 1 is a perspective view of a first embodiment of the vasculardevice of the present invention shown with the replacement valve removedfor clarity;

FIG. 2 is a perspective view of the vascular device of FIG. 1 shown withthe replacement valve;

FIG. 3 is top view of the intermediate portion of the valve support ofthe vascular device of FIG. 1 shown in a first position to define afirst gap;

FIG. 4 is a perspective view of the intermediate portion of the valvesupport of the vascular device of FIG. 1 shown with the gap of FIG. 3;

FIG. 5 is a top view similar to FIG. 3 showing a second smaller gap whenthe vascular device is placed in a smaller diameter vessel;

FIG. 6 is a perspective view of the intermediate portion of the valvesupport of the vascular device of FIG. 1 shown with the gap of FIG. 5;

FIG. 7A illustrates a delivery tube being inserted retrograde inside thevessel, upstream of the patient's valve leaflets, for delivery of thevascular device of FIG. 2;

FIG. 7B is a view similar to FIG. 7A showing withdrawal of the deliverytube to partially expose the vascular device of FIG. 2;

FIG. 7C shows full withdrawal of the delivery tube and full deploymentof the vascular device of FIG. 2 downstream of the patient's valveleaflets;

FIG. 7D is a view similar to FIG. 7C showing the vascular device movingto a smaller diameter due to the walls of the vessel;

FIG. 7E is a view similar to FIG. 7D showing the valve in an openposition to enable blood flow therethrough;

FIG. 7F is a view similar to FIG. 7E showing the valve in the closedposition to prevent blood flow therethrough;

FIG. 7G and 7H are views similar to FIG. 7F showing introduction of aretrieval device to engage the retrieval structure of the vasculardevice for retrieval from the vessel;

FIG. 8 illustrates placement of the vascular device of FIG. 2 upstreamof the patient's valve leaflets;

FIG. 9 illustrates an alternate embodiment of the vascular device of thepresent invention;

FIG. 10 illustrates one method of insertion of the vascular device ofthe present invention showing the delivery catheter inserted through thejugular vein for retrograde insertion into the popliteal vein;

FIG. 11 illustrates another method of insertion of the vascular deviceof the present invention showing the delivery catheter inserted throughthe right femoral vein for retrograde access to the popliteal vein;

FIG. 12 illustrates yet another method of insertion of the vasculardevice of the present invention showing a contralateral approach whereinthe delivery catheter is inserted through the left femoral vein foradvancement around the iliac vein for retrograde insertion into theright popliteal vein;

FIG. 13A shows a side view of the delivery device for the vasculardevice of FIG. 2, with the vessel wall shown in section, illustratingretrograde insertion of the delivery device in the popliteal vein; and

FIG. 13B shows a side view of the delivery device for the vasculardevice of FIG. 2, with the vessel wall shown in section, illustratingantegrade insertion of the delivery device in the popliteal vein;

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now in detail to the drawings where like reference numeralsidentify similar or like components throughout the several views, thedevice is designated generally by reference numeral 10 and has anelongated insertion position for minimally invasive insertion and anexpanded position when placed inside the vessel to provide a valve toreplace the patient's valve. The vascular device 10 can be used toreplace the patient's valve leaflets after the valve leaflets areremoved or placed upstream or downstream of the existing non-functioningvalve leaflets of the patient without having to surgically remove thevalve leaflets.

FIGS. 1 and 2 illustrate vascular device 10 of a first embodiment of thepresent invention in the expanded configuration, with FIG. 1 shownwithout the replacement valve attached for clarity.

Vascular device 10 includes a valve support 12 and a replacement valve48. Valve support 12 is preferably composed of a shape memory material,such as a nickel-titanium alloy, e.g. Nitinol, so that in its memorizedconfiguration it assumes the shape shown in FIGS. 1 and 2. This shapememory material characteristically exhibits rigidity in the austeniticstate and more flexibility in the martensitic state.

In some embodiments, to facilitate passage from the delivery catheter,the shape memory device is maintained in a collapsed configurationinside a delivery sheath or delivery catheter where it is cooled by asaline solution to maintain the device below its transition temperature.The cold saline maintains the temperature dependent device in arelatively softer condition as it is in the martensitic state within thedelivery sheath. This facilitates the exit of valve support 12 from thesheath as frictional contact between the device and the inner wall ofthe sheath would otherwise occur if the device was maintained in arigid, i.e. austenitic, condition. When the valve support 12 is releasedfrom the sheath to the target site, it is warmed by body temperature,thereby transitioning in response to this change in temperature to anaustenitic expanded condition. In other embodiments, the valve supportis maintained in a martensitic state within the delivery sheath(catheter) and then returns to its shape memorized austenitic whenexposed from the delivery tube.

The valve support 12 has an upstream portion 15, a downstream portion 16and an intermediate portion 18 positioned between the downstream portion16 and upstream portion 15. FIG. 7A illustrates the device 10 in thecollapsed position within a delivery tube (catheter) or sheath 60, thecollapsed position enabling minimally invasive insertion of the device10 to the target vessel. As shown, in the collapsed reduced profileposition the device is elongated, substantially aligned with alongitudinal axis of the delivery sheath 60, and when exposed throughthe distal opening 62 of the sheath 60, it moves to its expandedposition.

As used herein, antegrade, as is known in the art, denotes in thedirection of blood flow and retrograde denotes in a direction againstthe direction of blood flow. Upstream and downstream as is conventionalare used herein to correlate to the direction of blood flow which flowsupstream to downstream.

The valve support 12 of device 10 is preferably formed from shape memorywires. The first main wire 20 provides the retention for the device 10within the vessel. It also provides support for the replacement valve48. The second and third wires 51, 52, respectively, help to support thereplacement valve 48 and provide for adjustability of the valve asdescribed in more detail below.

In the expanded condition (configuration), at the upstream portion 15,at least one wire loop is formed, and in the illustrated embodiment twowire loops 30, 32 are formed. The wire loops or rings 30, 32 extendradially from the elongated portion 34 of wire 20 and preferably extendon only one side of wire 20 as shown. Stated another wire, wire 20 hasan elongated portion 34 extending longitudinally within the vessel, andloops 30, 32 extend in one direction with respect to the longitudinalaxis of the elongated portion 34.

The loops 30, 32 are shown substantially perpendicular to thelongitudinal axis of the elongated portion 34 so that theycircumferentially engage the circumference of the vessel wall andopenings through the loops 30, 32 enable blood flow therethrough. Thatis, a line passing through the center of the loops 30, 32 would besubstantially parallel to the longitudinal axis of the elongated portion34. Alternatively, the loops 30, 32 can be at acute angles with respectto the longitudinal axis of elongated portion 34.

In the expanded condition (configuration), at the downstream portion 16,at least one wire loop is formed, and in the illustrated embodiment twowire loops 40, 42 are formed. The wire loops or rings 40, 42 extendradially from the elongated wire 20, and preferably extend on only oneside of wire 20 as shown. That is, the wire loops 40 and 42 preferablyextend to the same side of elongated wire portion 35, and on the sameside as wire loops 30, 32. The loops 40, 42 are shown substantiallyperpendicular to the longitudinal axis of the elongated portion 35 sothat they circumferentially engage the circumference of the vessel walland openings through the loops 40, 42 enable blood flow therethrough.That is, a line passing through the center of the loops 40, 42 would besubstantially parallel to the longitudinal axis of the elongated portion35 and would also pass through the center of the loops 30, 32.Alternatively, the loops 40, 42 can be at acute angles with respect tothe longitudinal axis of elongated portion 35.

In a preferred embodiment, the elongated wire is a monolithic wire sothat the loops 30, 32, 40 and 42 are monolithically formed with the wire20. However, it should be appreciated in alternate embodiments, separatewires attached, e.g., welded, can be utilized to form the valve support12.

Also, although two wire loops are shown at the upstream portion 15 anddownstream portion 16, a different number of wire loops can be placed atthe downstream or upstream portion. For example, in the embodiment ofFIG. 9, vascular device 70 has a valve support 72 which includes aplurality of spiral wire loops, with multiple wire loops 74 at theupstream portion 76 and multiple wire loops 78 at downstream portion 80.In all other respects, valve support 72 and replacement valve 75 areidentical to valve support 12 and valve 14 of FIG. 2 and therefore forbrevity are not discussed in further detail since the structure andfunction is the same as in FIG. 2 and the insertion methods are the sameas described and illustrated herein.

Retrieval structure 36 is positioned on or adjacent an upstream tip ofthe main wire 20. Similarly, as an alternative or in addition toretrieval structure 36, retrieval structure 46 is positioned on oradjacent a downstream tip of the main wire 20. The retrieval structure36, 46 can include a ball, a hook or other structure which can begrasped by a removal tool, such as snare or grasper, to remove thedevice 10. By providing retrieval structure on both sides of the device10 in certain embodiments, the device 10 can advantageously be removedin either an antegrade or retrograde direction.

The intermediate portion 18 of valve support 12 includes a valvemounting section to function as the support for the valve 48. As shownin FIG. 1, the wire 20 loops a full 360 degrees to form a supportingloop 50. Attached to the supporting loop or ring 50 are wires 51 and 52.Wires 51 and 52 are also preferably made of shape memory material and inthe collapsed delivery position (condition) extend longitudinally alongthe wire 30. A first end 59 of wire 51 is fixedly attached to an upperportion of valve 48 and a second opposite end 56 is fixedly attached tocollar 54. Thus, wire 51 helps to secure valve 48 to valve support 12.Wire 52 has a first end 58 fixedly attached to an upper portion of thevalve 48 and a second opposite end 60 which extends through collar 62and is attached to collar 54. Wire 52 slides within collar 62 as thediameter of the supporting loop 50 changes to conform to the diameter ofthe vessel in which it is placed to thereby adjust the diameter of thevalve 48. That is, when the vascular device 10 is placed in a vessel,the diameter of the supporting loop 50 can change, e.g., be reduced indiameter and the wire 52 can slide to pull the valve 48 to a smallerdiameter position. This helps to maintain the desired configuration ofthe valve 48. In this manner of adjustment of the supporting loop 50 andthe valve 48, the vascular device 10 can be used in different sizedvessels.

This adjustability can be appreciated by comparing FIGS. 3-6. In FIGS. 3and 4, the supporting loop 50 of wire 20 has a first diameter Dl whichforms a gap G1 between the opposite directed portions 21, 23 of theelongate wire 20. FIGS. 5 and 6 illustrate what occurs if the vasculardevice 10 is placed in a smaller vessel. As shown, the supporting loop50 of wire 20 is moved inwardly to define a diameter D2 which is smallerthan the diameter D1 of FIG. 3. Likewise, the gap G2 formed between theportions 21, 23 of elongate wire 20 is less than the gap G1 of FIG. 4.The change in the valve dimension due to the sliding movement of wire 52can be appreciated by comparing FIGS. 7C and 7D. If placed in smallersized vessel, the supporting loop 50 is moved to smaller diameter in thedirection of the arrow of FIG. 7C and the wire 52 slides within thecollar 62 to pull the valve 48 to a smaller diameter as shown in FIG.7D.

The wires or struts 51, 52 can extend longitudinally along and externalto the valve 48 and then bend inwardly at an angle, for example an angleof about 90 degrees but other angles are also contemplated, to form aradial portion extending substantially transversely to the longitudinalaxis of the valve 48 to attach the valve 48. The valve 48 in someembodiments can include two spaced apart openings to accommodate passageof the radial portion of the wires 51, 52 to secure the valve to thestruts or wires 51, 52. This engagement fixes the wires to the valve 48,enabling the valve 48 to move between open and closed positions whilestill being retained. In other embodiments, the wires 51, 52, do nothave a radial portion and are attached to the valve at their downstreamends and/or along a portion or entire portion of the length of wires 51,52.

Various types of valves can be utilized. In the illustrated embodiment,valve 48 is a substantially conically shaped valve with a base 17attached to the supporting loop 50 and has slit valve 19 at itsdownstream end. In this manner, the slit valve 19 is closed (FIG. 7F)until the force of blood flow opens the valve to allow blood flowtherethrough as shown in FIG. 7E. Other types of valves are alsocontemplated, including for example duckbill valves or valves disclosedin U.S. Pat. No. 6,676,698, incorporated herein by reference in itsentirety. For example, the valve can have a plurality of leaflets orpetals arranged circumferentially thereabout. The leaflets can foldinwardly towards each other in the closed position to prevent bloodflow. The pressure of the blood during systole can force the leafletsapart to the open position. The valve opening can optionally be offsetfrom the central longitudinal axis of the vascular device.

There are several different methods of insertion of the vascular devicesof the present invention for treating venous valve insufficiency of thepopliteal or saphenous vein. Such methods of insertion that can beutilized include the methods disclosed in detail in the U.S. Pat. No.6,676,698 patent, which shows for example placement into the poplitealvein in the patient's leg and advanced to a region adjacent the leafletsto deploy the vascular device upstream of the leaflets. The deliverycatheter is explained as delivered in an antegrade fashion, with the tipextending downstream of the leaflets to deploy the device just upstream(defined in reference to the direction of blood flow) of the leaflets.

The vascular devices of the present invention can be inserted throughthe right jugular vein J (FIG. 10) through delivery sheath 90, where thedevice will be advanced through the superior and inferior vena cava,past the iliac vein, through the femoral vein and into the poplitealvein through leaflets in a retrograde fashion, i.e., opposite thedirection of blood flow. The delivery catheter can thus extend throughthe leaflet region just upstream of the leaflets or alternatively, justdownstream of the leaflets. The vascular devices of the presentinvention can alternatively be placed in the right femoral vein F (FIG.11) through delivery sheath 92, where it will be advanced in aretrograde manner to the popliteal vein P. In the contralateralapproach, it is inserted through the left femoral vein G (FIG. 12)through delivery sheath 94 where it will be advanced around the iliacvein and through the left femoral vein into the popliteal vein P.

In use, in one method, the catheter or delivery sheath is inserted overa conventional guidewire (not shown) so the distal tip of the sheathextends past, i.e., upstream, of the valve leaflets L extendingannularly from vessel wall of vessel V (FIG. 7A). As can be appreciated,since there is a gap between the valve leaflets, the valve cannotfunction properly because the leaflets cannot properly close to preventbackflow. Also, due to the malfunctioning of the valve, the vessel wallcan become dilated as the weight and pressure of the backflow bloodpushes out the vessel wall.

Once the position of the sheath 60 is confirmed by venography,intravascular ultrasound, or other means, the sheath 60 is withdrawnwith respect to the device 10 (FIG. 7B) to expose the device 10 so thesupport 12 returns to the memorized expanded configuration of FIG. 7C.To expose the device 10, a pusher can be advanced distally withindelivery sheath 60 against the end of the device 10, or the deliverysheath 60 can be withdrawn, or both the pusher and delivery sheath aremoved relative to each other. Note that device 70 can be inserted in thesame way as device 10 and therefore reference to insertion of device 10also contemplates inserting device 70.

The device is expanded to a larger diameter than the vessel diameter sothat loops 30, 32, 40, 42 will engage the vessel wall to apply asufficient radial force to secure the device 10 within the vessel. Thereplacement valve 48 remains inside the vessel and opens and closes torespectively enable and block blood flow therethrough. The valve support12 e.g., intermediate support loop 50 and valve 48, can then adjust tothe diameter of the vessel. In FIGS. 7C and 7E, the device 10 is placedupstream of the patient's valve leaflets L.

The vascular device 10 (and 70) can also be placed upstream (withrespect to the direction of blood flow) of the valve leaflets. Thedelivery catheter can be inserted in the same retrograde manner asdescribed above, except it is advanced adjacent but not past the valveleaflets L to enable downstream delivery of the device 10 (70) in anupstream position. The replacement valve 48 (75) would be placedupstream of the valve leaflets if left in the patient) or upstream ofthe region of the vessel where the valve leaflets were before removal.Thus, the replacement valve of the present invention can be utilized asa total replacement wherein the patient's valve leaflets are removed(such as in FIGS. 13A and 13B) or can be placed upstream or downstreamof the patient's leaflets, leaving the nonfunctioning leaflets in place(such as in FIGS. 7C-7H). FIG. 13A shows the delivery device 60 insertedretrograde in the popliteal vein; FIG. 13B shows the delivery device 60inserted antegrade in the popliteal vein.

The vascular device 10 is configured to minimize the insertion profile.To achieve this, the components of the device are aligned along alongitudinal axis during delivery.

As an alternative to shape memory, a stainless steel or polymericvascular support could be utilized.

Valve 40 is conically shaped as shown and is secured to the wire 20 ofthe vascular device 10 by various techniques. Other types of valves canbe utilized such as those described in the U.S. Pat. No. 6,676,698patent.

As described above, the vascular device can be placed in the poplitealvein, the femoral vein or other veins. Placement of two or more vasculardevices in the vein is also contemplated.

If it is desired to reposition or remove the device 10 (70), snare 66can be inserted within delivery catheter 60 or another introducersheath. The snare 66 is tightened around the retrieval structure 46 ofvascular device 10, as shown in FIG. 71-1.

Alternatively, a snare can be inserted from the other direction andtightened on retrieval structure 36 to enable repositioning or removalof the device 10.

The foregoing valves can be attached to the vascular devices by sewing,molding or other techniques. The valves can be composed of a variety ofmaterials such as PET, PTFE, polycarbonate polyurethane, swineintestinal submucosa, collagen and other biomaterials. The valve and/orthe vascular device surface can optionally be coated with anti-plateletor anti-thrombin/anti-clotting materials, 2 b/2 a coating, receptors,heparin coating, endothelial cell coating, etc.

While the above description contains many specifics, those specificsshould not be construed, as limitations on the scope of the disclosure,but merely as exemplifications of preferred embodiments thereof. Thoseskilled in the art will envision many other possible variations that arewithin the scope and spirit of the disclosure as defined by the claimsappended hereto.

What is claimed is:
 1. A vascular device for treating vein valveinsufficiency comprising: an elongated member having a first upstreamportion and a second downstream portion; a first retention portion atthe first upstream portion, the first retention portion movable from afirst elongated insertion position to an expanded position; a secondretention portion at the second downstream portion, the second retentionportion movable from a first elongated insertion position to an expandedposition: an intermediate looped portion positioned between the firstupstream portion and the second downstream portion; and a valvesupported by the intermediate looped portion and movable between an openposition to allow blood flow therethrough and a closed position toinhibit blood flow therethrough; wherein the intermediate looped portionis adjustable to loops of different diameters dependent on an innerdiameter of the vessel wall.
 2. The vascular device of claim 1, whereinthe first retention portion is a looped portion.
 3. The vascular deviceof claim 2, wherein the second retention portion is a looped portion. 4.The vascular device of claim 1, wherein the second retention portion isa looped portion.
 5. The vascular device of claim 3, wherein loops ofthe first and second retention portions are substantially perpendicularto a longitudinal axis of the elongated member.
 6. The vascular deviceof claim 1, wherein the first retention portion includes first andsecond looped portions.
 7. The vascular device of claim 1, wherein thesecond retention portion includes first and second looped portions. 8.The vascular device of claim 1, further comprising a collar mounted onthe intermediate looped portion.
 9. The vascular device of claim 1,further comprising first and second members extending from theintermediate looped portion to retain the valve.
 10. The vascular deviceof claim 9, wherein the second member is slidable with respect to theintermediate looped portion.
 11. The vascular device of claim 10,wherein the first member is fixedly attached to the intermediate loopedportion.
 12. The vascular device of claim 9, further comprising a firstcollar mounted on the intermediate looped portion, the second memberslidable within the first collar.
 13. The vascular device of claim 1,wherein the elongated member, the intermediate looped portion, the firstretention portion and the second retention portion are formed from asingle wire.
 14. The vascular device of claim 1, wherein the valve has asubstantially conical configuration.
 15. The vascular device of claim 1,further comprising retrieval structure at one or both of the upstreamportion and downstream portion of the elongated member for retrieval ofthe device.
 16. The vascular device of claim 1, wherein the first andsecond retention portions extend radially on one side of the elongatedmember.
 17. A method for treating venous valve insufficiency comprising:providing a vascular device including an elongated portion anddownstream, upstream and intermediate looped portions extending radiallyfrom the elongated portion, and a valve attached to the intermediatelooped portion; inserting into a target vessel a delivery device and thevascular device in an insertion position within the delivery device,wherein in the insertion position the downstream, upstream andintermediate looped portions have a reduced transverse dimension; andexposing the vascular device from the delivery device, wherein exposingthe vascular device enables the downstream, upstream and intermediatelooped portions to move to the expanded position, the intermediatelooped portion engaging an internal wall of the vessel and automaticallyadjusting to a diameter of the vessel.
 18. The method of claim 17,wherein a diameter of the valve is adjusted by a radial support attachedto the valve and slidably connected to the intermediate looped portion.19. The method of claim 18, wherein a collar is mounted to theintermediate looped portion and the radial support is slidable withinthe collar.